Regulatory Affairs Manager - Cambridge - excellent salary + benefits

My client is a world-leading global clinical research organisation with a truly global presence. Its continued expansion now leads to the need for an experienced Regulatory Affairs Manager to be based at its modern offices near Cambridge.

In this role you will report to the Director of Regulatory Affairs, Europe, and will provide strategic regulatory advice as well as managing projects in the provision of regulatory services. Your specific duties will be as follows:

To provide project specific regulatory services and co-ordination of projects
To provide regulatory strategy and product development advice to internal and external clients.
To manage, lead and train a small team of regulatory affairs professionals and consultants
To assist in business development, pricing of projects and budgeting for Regulatory Affairs in the company, including client contact as appropriate
To review and prepare regulatory submissions in Europe, South Africa and Pacific Rim and follow through with the relevant regulatory agencies
To provide a regulatory advisory and training service within the company

You will have around 5 years? experience in a broad range of regulatory affairs projects and will have acquired a good knowledge of the regulatory requirements in Europe, especially the UK and/or European clinical trials procedures. You must have a degree in Pharmacy or Life Sciences and ideally a higher qualification in a relevant subject. You must be able to demonstrate the ability to plan projects for several months ahead, and previous managerial or supervisory experience would be an advantage.

Key words: regulatory affairs, clinical trials, Europe

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